A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.

Completed · Phase 1

Conditions studied: Severe Sepsis

In brief

A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.

Key facts

Study ID

NCT02960854

Run by

Bristol-Myers Squibb

People needed

38

Starts

2016-12-07

Expected to finish

2018-01-05

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ages ≥ 18 years old
• Documented or suspected infection
• Severe sepsis or septic shock for at least 24 hours
• Sepsis-induced immunosuppression
• In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

You may not qualify if…

• Previous episode of severe sepsis or septic shock with ICU admission during the current hospitalization
• Autoimmune disease
• Organ or bone marrow transplant
• Cancer treatment in the past 6 weeks
• Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic hepatitis B virus (HBV) infection and not on treatment
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Uc Davis Medical Center — Sacramento, California, United States
• Univ. Of Colorado Health — Colorado Springs, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• University Of Florida — Gainesville, Florida, United States
• Pulmonary And Critical Care Of Atlanta — Atlanta, Georgia, United States
• Osf Saint Francis Medical Center — Peoria, Illinois, United States
• University Of Kentucky — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Michigan, Division of Acute Care Surgery — Ann Arbor, Michigan, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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